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Oxygen Concentrator
EUDAMEDClass IIa (EU MDR)
Ref 6840Model KSW-5
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- KSW-5 EUDAMED6840 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822531371 EUDAMED
- Basic UDI-DI
- B-06934822531371 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oxygen Concentrator by Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934822531371 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2698d7cc-8215-46a5-8c40-1d9f564ac41b 61 fields · synced May 23, 2026